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Tests treatment safety and results for Glaucoma
Official title A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
ClinicalTrials.gov ID: NCT07009236
What this study is testing
- What it's testing
- This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Males or females, 20 years of age or older
- Diagnosis of open angle glaucoma (OAG) in the study eye
- Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of...
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a...
- Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
You likely can't join if
- people are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to...
- Any eye surgery that was performed \< 90 days before Screening/Baseline visit in the study eye
- Diagnosis of diabetes mellitus with HbA1C \>7%
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
See the full eligibility criteria
Who can join
- Males or females, 20 years of age or older
- Diagnosis of open angle glaucoma (OAG) in the study eye
- Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction...
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include...
- Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
- Maximal C/D ratio must be 0.9 in the study eye
- people must be willing and able to follow study instructions and to return for scheduled study-related examinations
- people must provide written informed consent prior to any study procedures
- Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:
- Capsulorhexis is intact and centered
- Posterior capsular bag is intact
- The IOL is well-centered in the capsular bag
- There is no evidence of zonular dehiscence/rupture
- The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy.
What rules you out
- people are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation...
- Any eye surgery that was performed \< 90 days before Screening/Baseline visit in the study eye
- Diagnosis of diabetes mellitus with HbA1C \>7%
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
- Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant
- Central endothelial cell density (ECD) at Screening visit with a mean value \ 0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to...
- Anticipated need for ocular surgery or retinal laser procedure in the study eye
- Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,
- Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation
- Central corneal thickness greater than 600 microns
- Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders)
- Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye
- Evidence of crystalline lens subluxation or luxation in the study eye
- Inability to perform Visual Field (VF) testing in either eye
- Evidence of vitreous loss in the anterior chamber in the study eye
- Clinically significant intra-ocular inflammation or infection
- Presence of silicone oil in the study eye
- Participation in any study involving a drug or device within the past 3 months and planned participation to any other study during the present study. There is no exclusion period after completion of the present trial
- Only for women of childbearing potential: positive pregnancy test at Screening/Baseline visit. Pregnant or lactating women
- Subject is under tutorship or trusteeship
- Subject has a condition such that his / her ability to provide personal informed consent is compromised
- Diagnosis of cataract in the study eye that is not age-related e.g., traumatic, inflammatory or resulting from diabetes in the study eye
- Unable to discontinue anticoagulant/antiplatelet therapy (i.e. acetylsalicylic acid, coumadin, heparin, apixaban, etc.) for the surgical procedure. The amount of washout and when to restart therapy after surgery is at...
The study team makes the final eligibility decision.
Where it's taking place
- Santa Rosa de Copán, Honduras
- Colchester, United Kingdom
- Grimsby, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Rosa de Copán, Honduras; Colchester, United Kingdom; Grimsby, United Kingdom; Liverpool, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.